The world, especially the United States, is now facing a challenging rise in health care costs. Health care expenditures are rising rapidly. Contributing to this rise, there has been with a rapid increase in the number and spread of preventable illnesses and injury that are attributable to the unintended harmful effects of a variety of products and/or changes in the health status of an individual interacting with such products. According to projections by the Health Care Financing Administration of the United States Department of Health and Human Services, health care spending as a share of US gross domestic product (GDP) is estimated to increase from 13 percent to close to 20% of the United States GDP after the year 2000. This clearly demonstrates how unwise health care spending can affect the overall economy of a nation. The World Health Organization reported in 1995 that the percentage of total spending on health by various governments clearly indicated that health care costs are a serious global problem and an important factor concerning the overall utilization of public money. Public spending on health by the United States government was about 47%, by the United Kingdom was 84%, by France was 81%, by Japan was 78%, by Canada was 71%, by Italy was 70%, by Mexico was 56%.
The United States Department of Agriculture has estimated that the medical costs of illnesses caused by the unintended harmful effect of food alone amounted to over $34 billion dollars in 1998 (more than the combined global revenues in 1998 of Coca-Cola and Microsoft). It is easy to appreciate the threat to a nation's economy that such a situation presents. This, however, is only a fraction of the total medical cost created by the unintended harmful effect of products. The unintended harmful effect of prescription drugs, for example, resulted in an astonishing annual cost of $136 billion dollars in the United States. This is greater than all of the costs incurred as a result of heart disease (the number one cause of death in the United States). The above medical costs attributable to the unintended harmful effects of prescription drugs is more than the combined global revenues of all major airlines in the United States, England, Germany, Japan, France and Spain, which totaled $120 billion U.S. dollars in 1998. The situation is much more serious and inconceivably far more costly when the harmful effects of other consumer products are considered. This ultimately imposes a tremendous burden on the income tax payer and average worker, who at the end is the one paying for the vast majority of the costs associated with health care services. The fastest and most effective way to protect the public from an unsafe product and thus decrease such outrageous and unwise medical expenditures would be to timely and reliably identify, locate, and instruct the users of such unsafe products. Due to the seriousness of the harm and the rapidly increasing number of occurrences of harm and death caused by a variety of products, the government, private enterprises and medical organizations have an urgent need to find means and technology to prevent the spread and occurrences of illnesses and injuries that result from a failure to timely identify, locate, and treat users of harmful products. The ability to satisfy this need is critical to the containment of health care spending, not only in the United States, but also globally.
The development and use of a variety of medications (drugs) is essential to promoting health and treating a great number of disorders, while substantially increasing life expectancy. There are many benefits to the development of medications. Certain antibiotics, for example, have saved millions of lives. Antihypertensive drugs likewise have helped reduce the number of occurrences of strokes and heart disease, by controlling high blood pressure. The use of cholesterol lowering agents also have helped decrease the mortality rate associated with heart disease, the use of anti-depressants have helped millions of individuals better enjoy life, and the use of anti-glaucoma medications have helped millions of patients preserve their sight. The exhaustive process and laborious research involved with drug development have created many other breakthroughs and formidable drug discoveries which, in turn, have led to the control of previously untreatable diseases and a decrease in morbidity, while enhancing the quality of life and increasing life expectancy for millions of people across the world. However, these great benefits are associated with serious and costly problems due to the astonishing fact that not only thousands, but actually hundreds of thousands of patients die every year in the United States alone, as a result of drug reaction or unexpected and unintended adverse effects and reactions caused by prescription drugs.
Adverse drug reactions resulting from correctly administered FDA-approved drugs alone are responsible for the shocking figure of over 106,000 deaths per year in the United States alone. Adverse drug reactions are the fourth leading cause of death in the United States, immediately after heart disease, cancer, and stroke. The number of deaths caused by the harmful unintended effects of prescription drugs is amazingly more than the annual totals for AIDS, suicide, and homicide combined, and amount to more than twice the number of deaths due to accidents (which is about 40,000 per year). A person is more likely to die from an adverse effect of prescription medication than from accidents, diabetes, or lung disease. The staggering number of close to 300 deaths per day resulting from prescription drug adverse reactions remains unchanged due to the difficulties in timely identifying, locating, preventing use of the medication by, and treating the individuals at risk. In addition to the fatal events, there are typically over 2.2 million annual occurrences of non-fatal, but serious, reactions, and millions of complications and disabilities related to unexpected effects of drugs, chemical compounds and a variety of products which are responsible for some of the staggering health care spending that the world faces today. Unfortunately, this alarming picture will continue to worsen in the future, with devastating consequences to the economy, tax-payers and society as a whole if appropriate measures for prevention and the timely identification and location of the harmful products and affected individuals is not instituted to avoid spreading of potentially preventable injuries and disease.
The above catastrophic picture is even more grim and astonishing since the above figures exclude drugs which were improperly prescribed or improperly administered, as well as drug abuse and drug overdose and adverse effects caused by non-prescription drugs (over-the-counter medications), devices and other chemical compounds which are injected, ingested, or placed in or on the human body. If the adverse effects and fatal reactions related to the use of over-the-counter drugs (non-prescription drugs) and other products such as cosmetics were included the numbers would prove to be even more staggering. The risks, injury, and death caused by unintended adverse drug reactions and defective products could be substantially reduced if appropriate technology were implemented to provide the requisite notification, guidance, treatment, or the like.
The misuse of prescription and non-prescription drugs due to the inability to understand or identify a potential hazardous effect is also a critical cause of morbidity and mortality related to the utilization of a variety of products, devices, and chemical compounds. The ability to understand information about drugs, chemical compounds or devices is central to the prevention of some of the aforementioned devastating consequences. The U.S. Department of Education estimated that 47% of all adult Americans had poor reading and comprehension skills. Large amounts of medical material therefore can exceed the reading abilities of many American adults. Although there is information printed on the packages and product inserts that accompany prescription and over-the-counter drugs, as well as many other products, the majority of the population has difficulty understanding, interpreting, or using the information provided. As a result, many individuals suffer adverse effects due to their inability to understand the content of the information provided by the manufacturer and its relationship to his/her individual health status. It is important to remember that the health status of an individual is a dynamic process with continuous change over time. Such changes in the health status are quite capable of potentially interacting with chemical compounds and devices used by the patient and causing serious and even fatal effects and reactions. New technology is surely needed that will assist the user in safely using a drug despite his/her lack of knowledge regarding medical terminology and the interaction of drugs and products with the human body's continuously changing biological variables.
The prior art has provided several important home-testing technologies. Examples include several devices developed by the Applicant hereof. Such devices can be used by patients to self-administer measurements of eye pressure and perform a complete non-invasive blood analysis that includes evaluation of a variety of biological variables. Heretofore, there has been no convenient and reliable way of associating such home-testing devices with a notification, guidance, and/or treatment system, to provide a complete system of preventing negative interaction between chemical compounds used by the patient and changing biological variables of the patient. There is consequently a need for such a system. A brief example demonstrates the situation. Patients using some medications for the common cold or flu or products containing steroids may be at risk for damaging their eyes or even blindness if one biological variable, in this case, eye pressure is significantly increased. The increase in eye pressure can be silent, without any symptoms that would otherwise indicate that the individual may have glaucoma. The packet insert of the common cold pill and some skin lotions with steroids may have a warning against use of such products by those with glaucoma. Unfortunately, however, the person taking the pills or using the skin lotion typically does not know what glaucoma means, even after reading the packet insert, and will continue to use the product not knowing that there is a risk of eye damage. There is consequently a need for a system that will alert patients about such risks, regardless of the patient's knowledge of the meaning of the medical terminology in the packet insert and/or potential interaction with their health status and current biological variables.
The rapid rise in health care costs also relates to the disturbing fact that millions of patients suffer from severe complications, permanent disability, and death as a result of untimely identification of a health problem or untimely arrival at the medical provider or hospital. The medical costs associated with such untimely treatment cannot be overstated. There is consequently a need for a system that, in addition to preventing the harmful event from occurring, also can alert the user to seek treatment and arrange for treatment when such treatment becomes necessary as a result of injury or illness caused by a harmful product and/or changing biological variables.
Many adverse effects and reactions resulting from the use of chemical compounds and/or devices occur after the chemical compounds or devices are already in the marketplace and being used by potentially millions of consumers. The pre-marketing trials conducted during the evaluation process of drugs and devices frequently are not sufficient to reliably detect adverse effects and reactions and lack the requisite length of follow-up which is needed to evaluate the delayed consequences that manifest themselves only after chronic use or wide spread administration of drugs and devices. In addition to the limits associated with pre-marketing evaluation by the United States Food and Drug Administration (FDA) of drugs and devices, these trials do not include evaluation of the interaction of drugs with a variety of biological variables, nor do they involve evaluation of the result of use by special population groups that can be at a higher risk for adverse effects or reactions, when compared to the general population. Furthermore, the inability to identify the changes that occur in the healthy status of an individual such as changes in blood pressure, eye pressure, blood glucose, blood cholesterol, weight, and the like, make it virtually impossible to identify and prevent adverse reactions or effects that occur with the utilization of drugs and/or devices interacting with changing biological variables.
In order to identify and thus prevent the catastrophic complications due to the adverse effects of drugs, chemical compounds and devices that were not identified during pre-marketing evaluation, a post-marketing surveillance system has been instituted by the FDA. The sample size of the typical pre-marketing trial is small, with a short follow-up, when compared to the use of the drug by the general population in which thousands and even millions of patients will use the drug or devices for a long period of time with the consequent development of drug reactions. The post-marketing surveillance represents an attempt to address this limitation and relies on spontaneous reporting by health care providers and companies of adverse effects or reactions which were associated with the use of the chemical compounds, devices, cosmetics, or the like. The post-marketing surveillance system, however, includes no system or method adapted to directly alert the patients at risk. The post-marketing surveillance system instead relies basically on the physician informing patients on an individual basis. This is accomplished at the doctor's discretion and using his/her available resources. The primary objective of the post-marketing surveillance is to alert the health care provider and companies, but no system is in effect to directly address the individual user and all users of the harmful product.
The adverse events or reactions that result from the use of drugs, devices, cosmetics, or the like can occur during different stages of use (e.g., shortly after initiation of use, after long term use, and even much later, after the drug, chemical compound or device has been discontinued and/or recalled). Moreover, for each one report received by the FDA, it is estimated that there may be over 100 actual reactions. This demonstrates that the post-marketing surveillance reporting system used by health care providers substantially underestimates the actual number of adverse reactions and effects. Unfortunately, the most common way for a patient to discover that a product is harmful is after they have suffered injury or even death caused by the harmful product.
Besides the unintended detrimental effects caused by drugs and/or devices, the use of medications or devices may be associated with unintended beneficial effects. The post-marketing surveillance system also attempts to identify those beneficial effects and was key in identifying that hormonal therapy in post-menopausal women reduces death from cardiovascular disease, and that oral contraceptive users have a lower risk of ovarian cancer. There is consequently a need for a system and method that individually informs all of the users of a beneficial effect related to the particular drugs they are using.
The post-marketing surveillance system and prior art currently used suffer from many limitations and drawbacks, and is unable to efficiently identify, locate, prevent, and treat the unintended harmful effects of a variety of products after the product has been identified as harmful, as the above numbers clearly show and some of the following examples will further demonstrate.
A drug that was widely advertised on television by the name Loratadine and which is used to treat allergies, was found during post-marketing surveillance to cause esophagus rupture with even potentially fatal complications. The unexpected reason for this complication was identified as the size of the tablet for a particular formulation. The tablet was too large and caused blockages and subsequent potential rupture of the gastrointestinal tract. As a result of rupture, caustic gastrointestinal contents poured into the mediastinum and the surface of the heart, potentially leading to the demise of the patient. Although there was a great effort by the government and manufacturer to notify doctors and patients about this catastrophic event, many patients had no way of learning that their particular formulation of Loratadine could cause these completely unexpected complications, unless they were informed by their doctors or, in a few occasions, through the media. Due to the widespread use of this drug and the obvious difficulties in locating and alerting patients, astonishingly even after the announcement to doctors and the public by the FDA and the manufacturer about these devastating complications, patients unfortunately still were using the drug.
Another similar situation occurred with the antihistaminic drug called Terfenadine, which was subsequently found to cause potentially fatal arrhythmia when taken with certain antibiotics. In many cases, even after a drug has been discontinued and/or recalled, patients still use the recalled drug and are injured because it is virtually impossible for doctors, companies, and even the government to locate and inform all users of a particular drug about the complications. Drugs used by patients are usually manually written onto patients' charts. It would be necessary to manually review the thousands of charts for every medical practitioner and subsequently identify written information on the chart regarding different medications used by each patient. Since in most cases there is no indication about the date that a certain patient was started on a particular medication, this chart review would have to include the hundreds of pages that each chart may have. Of course this would have to be done any time a new adverse effect was identified for the drug as well as a new harmful drug was identified. Naturally, this is an insurmountable task. The data for each patient to be identified, located, and warned about the potential hazardous situation is impossible to retrieve in any practical manner. Sometimes the product does not need a prescription which makes the direct identification and location of the user impossible using existing record-keeping techniques. The problem is further demonstrated by a situation involving a shampoo capable of treating dandruff. That shampoo was later found to cause fatal reactions, blindness, diabetes, and other severe complications because of certain ingredients in its composition. Since this product was being sold over-the-counter without the need for a prescription, there is no way to identify who is using this extremely dangerous shampoo, even though it has been recalled and removed from the market. Users therefore continue to perish and suffer because they do not have access to the information on the hazards posed by the shampoo.
Unfortunately, the most common way that a user finds out about the potential harmful effects of product is by suffering the illness, injury or death caused by the harmful product. The above are only a few examples of real events that occurred in connection with such products. There are many other products causing harm and being recalled every year.
The picture is unfortunately more shocking and alarming when we consider the fact that defective products cause a similar amount of injury as described above, and even deaths as the following example will show. On May 12, 1998, a 17-month-old toddler died when his portable crib collapsed and strangled him at a licensed day-care facility in Chicago. The loss of a young child is surely irreparable, but more difficult to accept is the fact that it could have been prevented. Most astonishing is the fact that the portable crib that killed the young child had been recalled in 1993, five years earlier, by the United States Consumer Product Safety Commission (CPSC) and by the manufacturer. Neither the parents nor the day-care provider were aware of the recall. The crib collapsed wedging the toddler's neck inside the folded V of the rails and killing the child in one of the most horrifying ways, the inability to breath. The child was prevented from breathing and could not cry for help during the last minutes of his life. This same type of crib had already strangled and killed many children, but the available notification methods and system were inefficient and incapable of tracking, identifying, locating, and alerting the user about a potentially harmful and even deadly product. Although the recall was publicized several times, primarily through the news media, ads and other conventional, printed means, the message reached a very limited portion of the population and, even today, this deadly product is still present in many homes. It is important to remember that strangulation if not fatal, can lead to brain damage and a lifetime of nursing and institutional care for those unfortunate toddlers. There is consequently an increase in health care costs associated with these defective products, not to mention the emotional toll.
The following illustration will further demonstrate the inefficiency of existing systems and methods in recalling, tracking, and locating already known harmful drugs and other consumer products. Within weeks of the death of the aforementioned child, his parents began an urgent and massive e-mail campaign “Prevent death of next child” warning of the danger of the recalled portable cribs with the message being forwarded all over the U.S. and the world. The parents founded “Kids In Danger”, a charitable organization that warned millions of people in the U.S. and abroad about the dangers of recalled juvenile products by granting interviews to print, radio and television media and through E-mail and printed warning campaigns. The message reached various organizations, such as the American Academy of Pediatrics and other major medical and public organizations. Many of the respondents had a recalled crib but were not aware of the danger. Some of the responses to the e-mail posted by “Kids in Danger” demonstrate the magnitude of this alarming problem. The following are examples of such responses:
1). “The dissemination of recall information is horribly lacking. We have called all of the manufacturers of the equipment we use with our children and discovered that the carrier of our stroller has been recalled because it flips children out of the seat; we returned the warranty card over a year ago, when we purchased the stroller, and still were not notified of the recall. It is certainly clear now that parents and child care providers and state agencies need to be proactive in chasing this information down”
2). “I think it's bad that we have to really research in order to find out if a product we bought is considered safe. That safety seems to be an ever-changing line, does it not? I grieve with the families that have suffered; it is senseless.”
3). “I read the newspaper every day. I never heard about this danger to my children until now.”
This outstanding organization, “Kids in Danger”, issued a press release urging a far-reaching advertising campaign and began a nationwide television and print media campaign and also distributed public safety announcements to radio and television stations nationwide, encouraging consumers to call the CPSC to verify whether products in their possession have been recalled for safety problems. The massive nationwide and international e-mail campaign as well as massive media announcement, associated with extensive government actions that occurred after the death of the above-mentioned child were important and helpful, but unfortunately inefficient and limited by the existing systems and techniques for notification. Even after all of those efforts, the same needless tragedy happened again. On Aug. 19, 1998 (only 3 months after the aforementioned death), another innocent baby was killed by the same product in Fair Haven, N.J. The second baby was killed in the same terrifying manner. He was strangled to death when the same model of portable crib collapsed and crushed his throat. Unfortunately, the potentially life-saving recall information about the deadly crib never reached this innocent child's parents. It is clear that the commonly used systems and methods of notifying consumers suffer from severe limitations. It is incapable of reliably recalling and/or locating harmful products and the users of such harmful products.
Interestingly state inspectors had visited the day-care a week before one of the foregoing children died. The day care center's manager also had no idea the crib had been recalled. Despite a recall initiative by the City of Chicago, and the efforts of others, only about 15% of the 1.5 million portable cribs and play yards that were recalled, were actually accounted for. Thus, more than 1.2 million defective cribs remain in circulation. This further demonstrates the inefficiency and limitations of the existing notification and recall methods and systems.
According to Consumer Reports 99Buying Guide “the odds of your hearing about an unsafe product are slim. Manufacturers are reluctant to issue a recall in the first place because they can be costly. And getting the word out to consumers can be haphazard.” Likewise, according to the Kids in Danger organization, the only way to be certain that you are not using a recalled product is to check for yourself and periodically check with these government and private agencies about new recalls. Unfortunately, there is no commonly available method or system that actively searches and notifies individually and privately the user for all of the unique products that such users utilize and that informs the user about warnings/recalls for all the products being used by that individual user.
There are also web-sites that send undiscriminating and random recall information for virtually all recalled products, but it is obviously impossible and absolutely inappropriate to randomly send thousands of e-mails every day for each user with the user having to waste an incredible amount of time every day to sort through all of the thousands of daily messages received in order to identify a potentially harmful product that the particular user happens to be using. Furthermore, even if the user identifies among the thousands of daily messages the name of one product being used, the user would have to know if that particular product being used came from the plant or lot or section or processing area that corresponds to the product being recalled. The user then would have to check each package individually to try to find out if he/she has obtained a recalled product. There is consequently a need for a system or method that actively searches for the user and individually informs the user about a recalled product according to precise identification characteristics of the product such as processing plant, section, and the like. Since it is not practical or even appropriate to send thousands of daily messages to each of the millions of users, existing notification schemes select and send one message randomly to the user. There are clear limits and drawbacks to such a scheme. The individual user, for example, cannot afford the significant time, effort, and expense needed to sort through the millions of recalled products to find out which products being used by that user were actually previously recalled and to seek the warning information for each and every product being used by that user. Moreover, the user does not want to be inundated with the millions of recalls and warnings that do not correspond to the products being used by that user. Moreover, this indiscriminate e-mailing has proven to be unable to reach the user of a harmful product in a timely fashion, as the situation with the deadly crib demonstrated, with the tragic death of a second innocent child.
Notably, the existing notification systems tend to be user-based. That is, the user ultimately has to actively search for the recall and warning information about the products being used. Such systems therefore are not product-based and product-driven. There is a need, however, for a product-based and product-driven system and method, wherein an active search is conducted for all of the individual users of a particular product and the specific user of the unique product passively waits for the information about used products to reach him/her. In this regard, there is also a need for a method and system that provides such information to the user as soon as it becomes available.
In 1998 alone, the CPSC recalled more than 38 million individual units concerning harmful children's products. However, because most people never hear about these recalls, the majority of the recalled harmful products are still being used. CPSC usually relies on the media, printed material and manufacturers to recall harmful products voluntarily and most of the manufacturers cooperated. This, however, falls well short of guaranteeing effective results. During the past decade, 622 children have died in defective cribs, a rate of 57 children per year. In addition, at least 137,000 children were hurt. This translates to a rate of almost 400 child injuries per day. CPSC uses various means to inform the public. These include local and national media coverage, publication of numerous booklets and product alerts, a web site, a telephone Hotline, a Fax-On-Demand service, the National Injury Information Clearinghouse, and the CPSC's Public Information Center. There also are several web-sites and other means that publicly announce recalled products. However, they are not sufficient as the figures show. There is consequently a need for new means and technology capable of preventing those tragic events.
According to a CPSC spokesman, recalls also depend heavily on the cooperation of the news media. In the case of the aforementioned crib, the agency issues new press releases every time a child dies in the crib. The crib is also included in the agency's “recall roundup,” an annual news release that lists some of the most dangerous recalled products. The CPSC issues hundreds of press releases every year, including video news releases for television stations. This further demonstrates the long-standing need for a system capable of alerting users of potentially harmful products and thereby preventing injury.
Companies also are trying desperately to track and identify the recalled products as can be seen by another press release issued by the manufacturer of the deadly crib, after the death of the second baby in August of 1998. “This is a terrible tragedy we had hoped to prevent when we voluntarily recalled the Playskool Travel-Life crib in 1993 and immediately began extensive public awareness efforts to urge consumers to stop using the products”, an officer of the company said in his written statement. The manufacturer said that they franticly have done everything possible to recall the cribs after the death in May 1998. The company has, in fact, extensively advertised using all means, written directly to pediatricians and to all J. C. Penney catalog customers; mailed posters to stores that carried the cribs; set up a toll-free telephone hot line; and offered consumers $60 for the return of each crib (the cribs originally sold for about $89 each). Of course, all of that was not enough and one more child, among the many who died, was strangled to death, and the tragedy repeated.
Another critical issue related to the recall system currently used is the negative impact on the general reputation of business. This indirectly discourages companies from putting forth their best efforts to recall defective products. According to the United States CPSC, underreporting products that could cause injury or death is a very serious problem. This business concern, however, arises primarily because of the means by which both the CPSC and manufacturers inform the public. Typically, the news media and other forms of mass public disclosure are used. The bad publicity through the media has a devastating financial impact on the manufacturer of the recalled product. According to studies by Paul Rubin, former chief economist for the CPSC and professor of economics at Emory University, a company loses 7% of its revenues after each recall. It is easy to recognize the financial disaster faced by companies and the economy of the nation in general when the current, public means are used to alert users of potentially harmful products. There is consequently a need for a system and method capable of privately and individually alerting the user about a recalled and/or harmful product.
The current way of recalling also is very expensive. It therefore is difficult for companies to exert aggressive recall efforts. The federal government likewise is reluctant to impose too many restrictions on manufacturers because it could put hundreds if not thousands of companies out of business with the consequent uncontrolled increase in unemployment and the catastrophic effect on the economy of the nation. Although the government is to some extent charged with the responsibility of ensuring safety and protecting the population, the government is faced with a complex and perplexing challenge. It must balance the interest of safety on the one hand, against its interest in avoiding the consequences of forcing companies to spend money to recall products and to publicly advertise more aggressively their recalls of potentially harmful products (which could lead to increases in bankruptcy and the consequent irreparable damage to the economy of the nation). There is consequently a need to solve these problems associated with conventional recall techniques, by providing a system and method capable of privately and individually identifying, locating, and informing all users of a recalled product.
To find 10 deadly products that were sold to 10 out of 100 million potential purchasers is a daunting and currently virtually impossible task. Thus, 10 people can die because of the deadly effect of the harmful recalled products. Thus, there is a need for a system and method capable of individually identifying each particular product that is being recalled and the particular users of the product, and providing a warning to such users: This need for a system of identifying and warning all users of such potentially harmful products extends to one that, in addition to the savings in terms of lives, injury and costs provided thereby, can be implemented in a cost-efficient manner.
Recently, there has been an increase in the number of foods and other products that are imported and that are more likely to cause unintended harmful effects. Moreover, public sector spending on the consequences of adverse drug reactions is expected to accelerate since prescription drugs grew at double-digit rates during the last few years. This acceleration in prescription drug use can be attributed, at least in part, to the number of new life-saving drugs entering the marketplace, increased consumer demand induced by drug manufacturer advertising, and an increase in the number of prescriptions filled. It is expected that, in the year 2000, each American will use an average of 8 to 9 drugs. This will increase life expectancy and enhance quality of life, but also will cause unintended harmful effects. Besides rising utilization (number of prescriptions); there also will be an increase in intensity (including changes in size and mix of prescriptions) that, in turn, will lead to a greater risk for reactions. It will be virtually impossible to slow the growth on national health expenditures if there is no way to efficiently, privately, and timely identify, locate, prevent and provide guidance regarding potential injury and illness due to unintended harmful effects of products. For extended care, both nursing home and home health expenditures are expected to grow, as more people become disabled due to the unintended harmful effects of a variety of products. Left uncorrected, the number of injuries, illnesses and deaths due to the lack of timely identification and location of users of defective, contaminated products, and drug reactions, as well as illnesses caused by food, will boost the demand for medical services, exponentially increase health care costs, and cause significant increases in income tax to compensate for the rising cost of health care. There is consequently an urgent and vital need for technology that can privately, individually, timely, continuously, confidentially, reliably and/or cost-effectively track, identify, locate, inform and alert all of the users of potentially harmful products. It is also extremely desirable to have a system that returns only specific information relevant to the individual user of a unique product, and not random and/or mass information about a variety of products that do not relate to the user, thus avoiding the unnecessary transfer of information and documents that are not relevant to the user, and making it more practical and convenient (therefore more likely) for the user to become consciously aware of the warning.